LY4226695 for Healthy Participants
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the body processes a new drug, LY4226695, and identifies potential side effects in healthy individuals. Participants will receive the drug either by injection under the skin or directly into a vein, while some may receive a placebo. The trial consists of multiple parts, each requiring different durations of stay at the research center. It suits healthy individuals without significant medical issues who meet specific ancestry criteria for certain parts of the trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Is there any evidence suggesting that LY4226695 is likely to be safe for humans?
Research has shown that LY4226695 is being tested for safety and tolerability. Specific safety information is not yet available for those who might receive it under the skin. Similarly, detailed safety data is still being collected for intravenous administration.
As this trial is likely in its early stages, LY4226695 is probably being tested in humans for the first time. Consequently, information about potential reactions or side effects remains limited. Early-phase trials typically focus on understanding a treatment's safety and the body's response. This study will therefore gather important safety information about LY4226695.1Why do researchers think this study treatment might be promising?
Unlike the standard treatments available for various conditions, LY4226695 offers a unique approach by being administered both subcutaneously (Part A, B, C) and intravenously (Part D). Researchers are particularly excited about LY4226695 because it may introduce a new mechanism of action, differing from existing options that typically rely on well-known pathways. This flexibility in delivery methods and potential new way of working could lead to improved patient outcomes and broaden the scope of treatment options.
What evidence suggests that LY4226695 could be effective?
Research on LY4226695 remains in the early stages. The researchers are studying healthy participants to understand how the body processes this drug. The studies aim to determine the tolerance levels for LY4226695 and identify potential side effects. Participants in this trial will receive LY4226695 either subcutaneously or intravenously. Specific results regarding its effectiveness for any condition are not yet available, so the drug's potential benefits are still under exploration. Currently, the main goal is to gather safety information and understand its effects on the human body.12
Who Is on the Research Team?
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Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for healthy adults who do not have any significant medical conditions. Participants should generally be in good health and able to stay at the research facility as required by the study schedule.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A & D
Participants receive LY4226695 or placebo administered subcutaneously or intravenously. The study lasts about 64 days with a stay in the Clinical Research Unit (CRU) lasting at most 7 days.
Treatment Part B & C
Participants receive LY4226695 or placebo administered subcutaneously. The study lasts about 92 days with 5 stays in the Clinical Research Unit (CRU), each lasting at most 7 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY4226695
Trial Overview
The study is testing a new drug called LY4226695 compared to a placebo (inactive substance) in healthy people. It aims to see how safe the drug is, what side effects it may cause, and how the body processes it over several weeks.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive LY4226695 administered intravenously (IV)
Participants will receive LY4226695 or placebo administered SC
Participants will receive LY4226695 or placebo administered SC
Participants will receive LY4226695 or placebo administered subcutaneously (SC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
Health - NicheDB
... data consisting of diagnostic test results and clinical management i. Sep 22 ... A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing ...
Collaborative Neuroscience Research, LLC Trials
Aspeya, Inc. Safety in Asthma Patients. 03/27. 03/27. NCT07767487: A Study of LY4226695 in Healthy Participants. Not yet recruiting. 1. 148. US, RoW. LY4226695, ...
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